There are many devices that exists where they do not have ISO standards but still maybe in use. I believe that ISO are mandatory because any device that can endanger a person's life must not be used. ...

Design validation ensures that the device meet user needs and its intended uses. It is a design control activity that happens when the design development process is at its last stage. Design validatio...

One approach is certainly decreasing the time for animal studies. Reduced clinical trial can save some time to finish with the project as they take a lot of time for clinical trials and their results....

To cope up with the timeline for each and every member is necessary to avoid any unnecessary delay. For that a pin board should be kept attaching notes of all tge tasks. Not only that but also every u...

I think the tasks should be arranged in a way that if one task is completed early the other tasks that are independent of any other task that has to be completed during that time can be worked on. The...

I believe that there is a time factor not followed. As professor Simon mentioned that the early you start the early you finish and also matching the timeline of two different parts of the project is i...

I believe that missing a milestone at any point is bad. Sometimes it can cause a hell to the project and sometimes not. When it come to any project that is affected due to missing milestone it can cau...

One person working for multiple teams has its own pros and cons such as: Pros: It reduces artificial dependencies between projects. Reduces induced administrativeand context switching overhead. Increa...

Risk management is process of identifying, assessing, reducing and accepting risks. Efforts to avoid, mitigate and transfer risk can produce significant returns. In a project risk there is a complianc...

I read somewhere that closing phase has two important documents in the closure of the project. One is the formal project closure document and second is the lessons learned. Found it interesting and sh...

At this point there are number of important project documents. It covers aspects such as risks, actions, issues and decisions. These elements are kept in mind while working on the execution phase of t...

Planning phase is the most important and basic phase according to me. If you are planning it should be practical because after all it has to be executed. Each and every step of any project should be p...

I believe that if any project can wait to be done for that time it is not priority to complete it at that moment. Priorities are defined by timelines, if a project can wait while another project is cu...

Funding is the most essential part undoubtedly on medical industry. Anything attached with medical can cost more due to its safety regulations. For use internally or externally on human being. To be c...

There are ISO standards that are used by companies for launching any medical device in any country that doesn't have their medical standards or if they are not clear enough. The countries that have th...